New breeding technologies in plant sciences
|
|
- Edward Willis
- 6 years ago
- Views:
Transcription
1 New breeding technologies in plant sciences GPC-SEB workshop, 7-8 July 2017, Gothenburg, Sweden Historical Evolution of Biosafety Legislation and Key Definitions. Piet van der Meer : responsible for biosafety regulation in the Netherlands 2000 today: assisting governments and international organisations 2006 today: Faculties of Law and Sciences, Ghent Brussels, Belgium
2 Genetic Modification Traditional plant breeding x elite variety Related variety Genetic Modification any gene source
3 Genetic Modification Technical advantages, e.g.: More specific and faster Maintaining cultivar characteristics (breeding brings in difficult to remove unwanted genes) Possible with plants and animals that do not cross sexually Tweaking expression (e.g. stress induced, tissue specific) Much greater reservoir of genes; in principle any gene from any organism can be introduced in another organism.
4 Biosafety Historical highlights 1972: First publications on rdna 1974: Berg Letter published in Science, anticipated benefits and potential risks, calling for a voluntary moratorium. 1975: Asilomar : technique not inherently risky, but potential for novel combinations, safety case by case, end of moratorium. 1976: US-NIH Guidelines for rdna micro-organisms in laboratories 1978: Other countries follow, e.g. UK (1978), Netherlands (1979) 1986: OECD Blue Book, rdna safety recommendations; key concepts for risk assessment and risk management
5 Biosafety Regulations 1986: US coordinated framework for regulation of biotechnology 1990: EU Directives on Contained Use and Release of GMOs 1992: Agenda 21, maximise benefits, minimize risks >>> Convention on Biological Diversity 1996: Canada (CFIA, Health Canada) 2000: Cartagena Protocol on Biosafety - transboundary movement ~ 2000 onwards: Review and revision of regulatory systems (e.g. EU) ~ 2010 onwards: Are organisms developed through NBTs covered by the regulations? Depends on the definitions
6 Definitions - History 1986: OECD Blue Book : Definitions of genetic manipulation and recombinant DNA varies in detail between countries, but rdna organisms are described as constructed by introducing DNA from a donor organism into a recipient E.g.: UK: formation of new combinations of heritable material by the insertion of nucleic acid molecules, produced outside the cell, via vector system so as to allow their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation.
7 Definitions Historical highlights Debate as of the mid 80s: which organisms should be subject to prior risk assessment? Observations put forward: Conventional breeding and rdna can both result in novel genetic combinations that can cause adverse effects rdna techniques themselves do not confer risky characteristics rdna can make a broader range of novel combinations Options discussed: Include all conventionally produced organisms? Focus on risky organisms? Focus on novel organisms?
8 Which organisms subject to prior risk assessment? Considerations: Include all conventionally produced organisms: is there an unmet need to include them? Focus on Risky organisms: how to define which are risky? Focus on Novel organisms: how to define novel? Genotypic and/or phenotypic? Does not exist or is unlikely to happen? >> Different approaches in different systems, most focus on novelty
9 US Coordinated Regulatory Framework for Biotechnology Department of Agriculture (USDA-APHIS-BRS) Plant Protection Act (PPA) Environmental Protection Agency (EPA) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) FFDCA: Setting allowable levels of pesticides in food Toxic Substances Control Act (TSCA) Food and Drug Administration (FDA) Federal Food, Drug and Cosmetic Act (FFDCA)
10 Definitions: USA - USDA USDA Plant Protection Act, Protecting against damage from plant pests and noxious weeds Regulatory trigger: the use of genetic engineering in combination with the use of plant pest as recipient, donor or vector, in the transformation process.
11 Definitions: USA FDA FDA: Authority based on Federal Food, Drug and Cosmetic Act (FFDCA) Guidance in the Federal Register of 1992: The 1992 policy applies to foods developed from new plant varieties, including varieties that are developed using recombinant deoxyribonucleic acid (rdna) technology (which is often referred to as "genetic engineering" or "biotechnology"). This guidance document refers to foods derived from plant varieties that are developed using rdna technology as "bioengineered foods."
12 Definitions: USA EPA EPA: authority based on FIFRA, FFDCA, TSCA: Plant-Incorporated Protectant (PIP, 2001) - a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for the production of such a pesticidal substance. " PIPs developed through conventional breeding will remain exempt from all FIFRA and FFDCA requirements, with the exception of adverse effects reporting requirements for manufacturers.
13 Definitions: EU (1990/2001) GMO means an organism in which the genetic material has been altered in a way that does not occur naturally; Annex: Genetic modification occurs at least through the use of: rdna techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation; Direct introduction, e.g. macro injection fusion techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.
14 Definitions Canada (1996) CFIA (1996, based on the Seeds Act and Feed Act) and Health Canada (Food and Drug Act) Plants with novel traits fall under the regulatory trigger of the seeds regulations if: They have a novel trait that was not present prior to December 1996 in germplasm of the same species in Canada, and that plant poses an environmental risk.
15 Definitions CPB Cartagena Protocol on Biosafety: (2000) "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology; Modern biotechnology" means the application of: - In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or - Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;
16 Definitions - EU Question whether and to what extent organisms developed through NBTs such as genome editing fall under the definition of GMO. Discussion: Altered in a way that does not occur naturally? Refers to: Process/technique? The product/resulting organisms? Both?
17 Definitions - EU Legal clues: The law itself, explanatory notes, Jurisprudence, doctrine The final word is with the European Court of Justice (ECJ). Interpretation by the ECJ: the wording, general scheme and spirit Literal interpretation, text of the definition and the annexes When the wording in itself is not conclusive: Systemic interpretation (general scheme), internal and external consistency (e.g. CPB) Dynamic interpretation, e.g. teleological or functional, see ERA, pushing an interpretation to its limits [See also Callebaut 2015]
18 Definitions EU (2001) GMO means an organism in which the genetic material has been altered in a way that does not occur naturally; Annex: Genetic modification occurs at least through the use of: rdna techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation; Direct introduction, e.g. macro injection fusion techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.
19 Definitions - EU My conclusion: For an organisms to fall under the EU definition of GMO requires a) the use of certain techniques ( trigger ) and b) a certain level of novelty of the resulting combinations of genetic material. E.g. small point mutations obtained through genome editing would not result in a GMO.
20 Definitions - EU Views of others and other views: European Commission: formulating views by taking into account reports of a WGNBT (2012), EFSA, JRC and Legal Services Confirmed in reply to MEPs, both process and product relevant D and SE authorities have formally concluded that certain organisms developed through ODM and CRISPR are not GMOs D, UK, IRL and ES confirmed in a letter to the EC that the EU GMO definition relies on the technique and the resulting organism. Some NGOs adhere to a process based interpretation arguing that these technologies are considered likely to bring negative impacts on human and/or environmental health.
21 Distinguish various categories: Future Regulation Mixing genes between sexually compatible organisms: cross breeding, hybrids, marker assisted selection, embryorescue, polyploidy, cis-genesis, Generating genetic variation within existing genomes: mutation breeding, genome editing. Generating novel genetic combinations: e.g. Introducing traits from an unrelated organism into another: genetic modification/genetic engineering.
22 TACK!
Regulation of New Plant Breeding Techniques in Canada and the United States
Regulation of New Plant Breeding Techniques in Canada and the United States New Breeding Techniques RNA interference Cisgenesis and intragenesis Oligonucleotide directed mutagenesis Grafting (on transgenic
More informationRegulation of Agricultural Biotechnology in the United States: Overview
Regulation of Agricultural Biotechnology in the United States: Overview Webinar for: National Agricultural Law Center July 15, 2015 Michael J. Firko, Ph.D. APHIS Deputy Administrator (BRS) History of Plant
More informationUSDA-APHIS Biotechnology Regulatory Services Janet L. Bucknall Associate Deputy Administrator
USDA-APHIS Biotechnology Regulatory Services Janet L. Bucknall Associate Deputy Administrator National Conference of State Legislatures Capitol Forum, Washington DC December 8, 2015 USDA APHIS BRS Mission
More informationPocket K No. 8. Cartagena Protocol on Biosafety
Pocket K No. 8 Cartagena Protocol on Biosafety In 1994, the first genetically modified food crop, Calgene s Flavr-Savr tomato, was produced and consumed in an industrialized country. Since that time, genetically
More informationUSDA Regulation of Organisms Developed Through Modern Breeding Technologies
USDA Regulation of Organisms Developed Through Modern Breeding Technologies Neil E. Hoffman USDA-Animal and Plant Health Inspection Service Riverdale, Maryland neil.e.hoffman@aphis.usda.gov The federal
More informationTransport of Genetically Modified Micro-organisms and Organisms or Living Modified Organisms (LMOs)
Page 1 COMMITTEE OF EXPERTS ON THE TRANSPORT OF DANGEROUS GOODS AND ON THE GLOBALLY HARMONIZED SYSTEM OF CLASSIFICATION AND LABELLING OF CHEMICALS Sub-Committee of Experts on the Transport of Dangerous
More informationBiosafety and Biosecurity in the Context of the Cartagena Protocol on Biosafety. David Duthie, UNEP-DGEF, Geneva, Switzerland
Biosafety and Biosecurity in the Context of the Cartagena Protocol on Biosafety David Duthie, UNEP-DGEF, Geneva, Switzerland The Protocol originated from Article 19(3) of the Convention on Biological Diversity,
More informationNew developments in modern biotechnology: A survey and analysis of the regulatory status of plants produced through New Breeding Techniques
Faculty of Law Ghent University 2014-2015 New developments in modern biotechnology: A survey and analysis of the regulatory status of plants produced through New Breeding Techniques Master thesis submitted
More informationCanadian Perspectives on the "Novelty" Trigger for Environmental Release of PNTs. Heather Shearer CFIA Plant Biosafety Office
Canadian Perspectives on the "Novelty" Trigger for Environmental Release of PNTs Heather Shearer CFIA Plant Biosafety Office OUTLINE Canadian regulatory framework for biotechnology Plants with novel traits
More informationIBC protocol Risk Assessment and Determination of NIH Guidelines
IBC protocol Risk Assessment and Determination of NIH Guidelines The following are points to consider when reviewing all protocols for risk, recommended containment conditions, and determine applicable
More informationKey words: Codex Alimentarius Commission (Codex); Committee on Food Labeling (CCFL); genetically modified (GM); international harmonization.
AgBioForum Volume 3, Number 4 2000 - Pages 203-208 THE PROCESS OF DEVELOPING LABELING STANDARDS FOR GM FOODS IN THE CODEX ALIMENTARIUS Anne A. MacKenzie 1 The Codex Committee on Food Labeling (CCFL) is
More informationMaintaining Plant Product Integrity. OF Biotechnology-Derived Plant Products
GUIDE FOR Maintaining Plant Product Integrity OF Biotechnology-Derived Plant Products 1 Guide for Maintaining Plant Product Integrity of Biotechnology-Derived Plant Products DISCLAIMER The Guide for Maintaining
More informationSupplement to ISPM No. 11 (Pest risk analysis for quarantine pests) PEST RISK ANALYSIS FOR LIVING MODIFIED ORGANISMS
Supplement to ISPM No. 11 (Pest risk analysis for quarantine pests) PEST RISK ANALYSIS FOR LIVING MODIFIED ORGANISMS The purpose of this supplementary text is to provide detailed guidance to National Plant
More informationGENETICALLY MODIFIED (GM) CROPS AND BIOSAFETY** Prof S.Kannaiyan*
1 GENETICALLY MODIFIED (GM) CROPS AND BIOSAFETY** Prof S.Kannaiyan* Introduction: Biotechnology is emerging as one of the most innovative achievements in the life sciences and influencing almost every
More informationevaluate risk / benefit implications ascertain applicability of existing legislation
1 Scope & purpose Regulatory implications of NBTs evaluate risk / benefit implications ascertain applicability of existing legislation assess robustness of current regulatory framework and risk analysis
More informationScientific Advice Mechanism. Scoping paper: New techniques in agricultural biotechnology
Scientific Advice Mechanism Scoping paper: New techniques in agricultural biotechnology 25 November, 2016 Policy context New techniques in agricultural biotechnology During the past decade a number of
More informationWhat if Biotechnology is the only answer to HLB? June 16, 2016
What if Biotechnology is the only answer to HLB? June 16, 2016 Why is Southern Gardens Involved in Research? 6/21/2016 2 Southern Gardens Disease Research Finding a solution to the HLB Greening disease
More informationCBD. Distr. GENERAL. UNEP/CBD/BS/COP-MOP/8/INF/6 23 November 2016 ENGLISH ONLY
CBD Distr. GENERAL UNEP/CBD/BS/COP-MOP/8/INF/6 23 November 2016 ENGLISH ONLY CONFERENCE OF THE PARTIES TO THE CONVENTION ON BIOLOGICAL DIVERSITY SERVING AS THE MEETING OF THE PARTIES TO THE CARTAGENA PROTOCOL
More informationTHE CALIFORNIA RIGHT TO KNOW GENETICALLY ENGINEERED FOOD ACT
The people of the State of California do enact as follows: THE CALIFORNIA RIGHT TO KNOW GENETICALLY ENGINEERED FOOD ACT SECTION 1. FINDINGS AND DECLARATIONS (a) (b) (c) (d) (e) (f) (g) (h) California consumers
More informationShould EU Legislation Be Updated?
Should EU Legislation Be Updated? Scientific developments throw new light on the process and product approaches COGEM Report CGM/090626-03 COGEM Report CGM/090626-03 Netherlands Commission on Genetic Modification
More informationREGISTRATION DOCUMENT FOR RECOMBINANT DNA RESEARCH
EHRS Date Received: Reg. Doc. No.: REGISTRATION DOCUMENT FOR RECOMBINANT DNA RESEARCH Principal Investigator: Penn ID#: Position Title: School: Department: Mailing Address: Mail Code: Telephone: FAX: E-mail:
More informationOfficial Journal of the European Union. (Acts whose publication is obligatory)
5.11.2003 L 287/1 I (Acts whose publication is obligatory) REGULATION (EC) No 1946/2003 OF THE EUROPEAN PARLIAMT AND OF THE COUNCIL of 15 July 2003 on transboundary movements of genetically modified organisms
More informationBt d-endotoxins are globular protein molecules, which accumulate as protoxins in crystalline form during late stage of the sporulation.
Bt Corn Bt d-endotoxins are globular protein molecules, which accumulate as protoxins in crystalline form during late stage of the sporulation. Protoxins are liberated in the midgut after solubilization
More informationGreening-Resistant Genetically- Enhanced Trees: A case study. Michael S. Irey
Greening-Resistant Genetically- Enhanced Trees: A case study Michael S. Irey Huanglongbing aka Citrus Greening Found in Florida in 2005 Now found along with it s vector in: Florida (endemic) Georgia South
More informationFOREWORD. Karma Dorji Director General
1 2 FOREWORD Bhutan Agriculture and Food Regulatory Authority (BAFRA), Ministry of Agriculture and Forests is committed to implement regulatory measures related to food safety and protection of human health
More informationTHE LAW ON GENETICALLY MODIFIED ORGANISMS
THE LAW ON GENETICALLY MODIFIED ORGANISMS I. BASIC PROVISIONS Article 1 This Law regulates the conditions for contained use, deliberate release into the production, and placing on the market of genetically
More informationNIH Guidelines for rdna Research: Tutorial for Completing Penn s rdna Registration Document
NIH Guidelines for rdna Research: Tutorial for Completing Penn s rdna Registration Document Revision March 3, 2011 Penn s rdna Registration Document Dual Use Research Definition: Research that yields information
More informationUnapproved Genetically Modified Wheat Discovered in Oregon: Status and Implications
Unapproved Genetically Modified Wheat Discovered in Oregon: Status and Implications Tadlock Cowan Analyst in Natural Resources and Rural Development June 7, 2013 CRS Report for Congress Prepared for Members
More informationCHAPTER 9: GENETIC ENGINEERING DR. BERTOLOTTI
CHAPTER 9: GENETIC ENGINEERING DR. BERTOLOTTI Essential Question How and why do scientists manipulate DNA in living cells? 1 What is selective breeding used for? Application of Genetic Engineering Video:
More informationPREPUBLICATION CODEX PRINCIPLES AND GUIDELINES ON FOODS DERIVED FROM BIOTECHNOLOGY CONTENTS
PREPUBLICATION CODEX PRINCIPLES AND GUIDELINES ON FOODS DERIVED FROM BIOTECHNOLOGY CONTENTS PRINCIPLES FOR THE RISK ANALYSIS OF FOODS DERIVED FROM MODERN BIOTECHNOLOGY... 1 GUIDELINE FOR THE CONDUCT OF
More informationWhat is Biotechnology?
What is Biotechnology? Biotechnology is a modern technology that makes use of organisms (or parts thereof) to: make or modify products; improve and develop microorganisms, plants or animals; or develop
More informationNew Breeding Techniques Platform
New Breeding Techniques Platform Ref. Ares(2014)4258256-17/12/2014 "k. Plants,--'-"' for lhe ruture Irurūpcan Technology Plarfwn Multilateral Meeting on The Future of Plant Breeding Techniques i 1le European
More informationKeller and Heckman LLP Serving Business through Law and Science. Genetically Modified Organisms and TSCA
Keller and Heckman LLP Serving Business through Law and Science Genetically Modified Organisms and TSCA The Technology Biotechnology s role in sustainable environment Concern: novel behaviors, in some
More informationBIOSAFETY AND ENVIRONMENTAL ISSUES
BIOSAFETY AND ENVIRONMENTAL ISSUES Muiru, W.M University of Nairobi Department of Plant Science & Crop Protection University of Nairobi ISO 9001:2008 1 Certified http://www.uonbi.ac.ke Definitions Biosafety
More informationSECTION I CITIZENSHIP: CITIZENSHIP: SECTION II
APPLICATION FOR INSTITUTIONAL BIOSAFETY COMMITTEE REVIEW AND APPROVAL South Dakota School of Mines and Technology (Protocol Submission Form) This form must be submitted for ALL research or teaching activities
More informationWhy Biotech Solutions are Needed to Address Forest Health. Steve Strauss Oregon State University / USA
Why Biotech Solutions are Needed to Address Forest Health Steve Strauss Oregon State University / USA Why advocate for recdna tech? Science rdna starts from nature Innovation Builds on nature to enhance
More informationRegulation of Biotechnology: needs and burdens for developing Countries
Regulation of Biotechnology: needs and burdens for developing Countries Julian Kinderlerer Sheffield Institute of Biotechnological Law & Ethics, The University of Sheffield, Sheffield S10 2TN, United Kingdom
More informationChapter 9. Biotechnology and DNA Technology
Chapter 9 Biotechnology and DNA Technology SLOs Compare and contrast biotechnology, recombinant DNA technology, and genetic engineering. Identify the roles of a clone and a vector in making recombined
More information[ 2 ] [ 3 ] WHAT IS BIOTECHNOLOGY? HOW IS BIOTECHNOLOGY DIFFERENT FROM THE TRADITIONAL WAY OF IMPROVING CROPS?
WHAT IS BIOTECHNOLOGY? Biotechnology is a modern technology that makes use of organisms (or parts thereof) to make or modify products; improve and develop microorganisms, plants or animals; or develop
More informationRegistration Document For Biohazards
Protocol #: Registration Document For Biohazards All applicants are required to complete the following sections: Principal Investigator Information Location of Study Section A: General Administrative Information
More informationMolecular assessment of GMOs Ilona Kryspin Sørensen PhD DTU Food Division for Risk Assessment and Nutrition
Molecular assessment of GMOs Ilona Kryspin Sørensen PhD DTU Food Division for Risk Assessment and Nutrition Objective : to assess the level of documentation necessary for the evaluation of the insertion
More informationTutorial for Completing Penn s r s DNA Registration Document
NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES NIH GUIDELINES Tutorial for Completing Penn s r s DNA Registration Document Revision March 7, 2013 Penn s r s DNA Registration
More informationAt the crossroadswhat future for plant breeding innovation in Europe?
At the crossroadswhat future for plant breeding innovation in Europe? THE EUROPEAN SEED SECTOR Diverse > 7.000 companies > 90% micro enterprises & SMEs Competitive leading innovator leading exporter Innovative
More informationBiosafety Level Host Range Propagation Comments
Guidelines BSL for Commonly used Viral Vectors Version 1.0 Office of Animal Care and Institutional Biosafety (OACIB) 1737 West Polk Street (MC 672) 206 Administrative Office Building Chicago, IL 60612
More informationBIOTECHNOLOGY OLD BIOTECHNOLOGY (TRADITIONAL BIOTECHNOLOGY) MODERN BIOTECHNOLOGY RECOMBINANT DNA TECHNOLOGY.
BIOTECHNOLOGY Biotechnology can be defined as the use of micro-organisms, plant or animal cells or their components or enzymes from organisms to produce products and processes (services) useful to human
More informationSpecial event on the risk assessment of new plant breeding techniques
Special event on the risk assessment of new plant breeding techniques Summary Authors: Anita Greiter 1 Marion Dolezel 1 Michael Eckerstorfer 1 Alexandra Ribarits 2 Walter Stepanek 2 Markus Wögerbauer 2
More informationSafe Operating Procedure
Safe Operating Procedure RECOMBINANT OR SYNTHETIC NUCLEIC ACIDS IBC AND OTHER REVIEW REQUIREMENTS (For assistance, please contact EHS at (402) 472-4925, or visit our web site at http://ehs.unl.edu/) (Revised
More informationThe use of bioinformatic analysis in support of HGT from plants to microorganisms. Meeting with applicants Parma, 26 November 2015
The use of bioinformatic analysis in support of HGT from plants to microorganisms Meeting with applicants Parma, 26 November 2015 WHY WE NEED TO CONSIDER HGT IN GM PLANT RA Directive 2001/18/EC As general
More informationCOMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE 1 : DNA VACCINES NON-AMPLIFIABLE IN EUKARYOTIC CELLS FOR VETERINARY USE
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Veterinary Use CVMP/IWP/07/98-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE 1 : DNA VACCINES
More informationBiosafety Clearing-House and the Network of Laboratories
and the Network of Laboratories 2nd International Workshop of GMO Analysis Networking 21-23 July 2015, Varese, Italy Manoela Miranda & Dina Abdelhakim Cartagena Protocol on Biosafety Convention on Biological
More informationRules and Regulations on GMO-derived food products in the European Union Lynn Insall UK Food and Drink Federation
Rules and Regulations on GMO-derived food products in the European Union Lynn Insall UK Food and Drink Federation Food Safety Workshop, Cairo, 17 April 2005 About the UK Food and Drink Manufacturing Industry
More informationREGULATORY COMPETITIVE SHELTERS AS INCENTIVES FOR INNOVATION IN AGROBIOTECH
REGULATORY COMPETITIVE SHELTERS AS INCENTIVES FOR INNOVATION IN AGROBIOTECH Yaniv Heled, J.S.D. * 2015 MICH. ST. L. REV. 553 Regulatory competitive shelters 1 (RCSs; a.k.a. regulatory exclusivities) are
More informationWhat is Biotechnology? Micro 566 Microbial biotechnology Presented by Prof. Nagwa M. Aref
What is Biotechnology? Micro 566 Microbial biotechnology Presented by Prof. Nagwa M. Aref 1.1 Defining Biotechnology Biotechnology- the study and manipulation of living things or their component molecules,
More informationThe radiata pine estate and the regulation of GM forestry trees in New Zealand. Dr. Tim Strabala, Principal Scientist, New Organisms
The radiata pine estate and the regulation of GM forestry trees in New Zealand Dr. Tim Strabala, Principal Scientist, New Organisms Plantation forests in New Zealand New Zealand s plantation forestry estate:
More informationBIOTECHNOLOGY. Understanding the Application
BELLRINGER-5/4/15 1. What method would you guess forensic scientists use to identify criminals at crime scenes? 2. What do you think we mean by the term biotechnology? BIOTECHNOLOGY Understanding the Application
More informationGM Food Safety: Philippine Regulations and Food Safety Assessment
GM Food Safety: Philippine Regulations and Food Safety Assessment Institutional framework What are the bodies (authorities) involved in regulation and risk assessment of GMOs? Department of Agriculture
More informationGenetics Lecture 21 Recombinant DNA
Genetics Lecture 21 Recombinant DNA Recombinant DNA In 1971, a paper published by Kathleen Danna and Daniel Nathans marked the beginning of the recombinant DNA era. The paper described the isolation of
More informationECOROPA. Potential Ecological and Social Impacts of Genetically Engineered Trees
ECOROPA Stop GE Trees Campaign Potential Ecological and Social Impacts of Genetically Engineered Trees Commentary on CBD/SBSTTA/INF/6 Paper on Potential Impacts of GE Trees Prepared for CBD SBSTTA Meeting,
More informationChallenges for biosafety in the rapid changing field of biotechnology
Challenges for biosafety in the rapid changing field of biotechnology Gijsbert van Willigen, PhD Coordinator CBRN Safety & Security LEIDEN UNIVERSITY MEDICAL HOSPITAL 1Insert > Header & footer 14-Apr-17
More informationBiosafety and the NIH Guidelines
Biosafety and the NIH Guidelines This section will explore: Why the NIH Guidelines are important The definition of recombinant or synthetic nucleic acid research Content of the NIH Guidelines Section III
More informationNew Plant Breeding Techniques
New Plant Breeding Techniques What future for breeding innovation in Europe? Garlich v. Essen ; GMCC ; Amsterdam; 18.11.2015 THE EUROPEAN SEED SECTOR Diverse > 7.000 companies > 90% micro enterprises &
More informationAPPLICATION FOR INTENTIONAL INTRODUCTION (CONDUCT A TRIAL RELEASE) OF GENETICALLY MODIFIED ORGANISMS (GMOs) INTO THE ENVIRONMENT OF SOUTH AFRICA
DIRECTORATE GENETIC RESOURCES Private Bag X973, Pretoria, 0001 Harvest House Room 167, 30 Hamilton Street, Arcadia, Pretoria, 0002 Tel: 12 319 6382, Fax: 12 319 6298, E-mail: NompumeleloM@daff.gov.za APPLICATION
More informationCibus. Harnessing the Power of Bio-Diversity. Cibus Rapid Trait Development system (RTDS ) is an environmentally friendly smart breeding tool.
Cibus Harnessing the Power of Bio-Diversity Cibus Rapid Trait Development system (RTDS ) is an environmentally friendly smart breeding tool. 1. Cibus Development stage company with offices located in San
More informationThis document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
2001L0018 EN 21.03.2008 003.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents B DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT
More informationCOMMITTEE USE ONLY IBC REGISTRATION
BRF September 2016 Page 1 of 6 COMMITTEE USE ONLY IBC REGISTRATION # ASSOCIATED ACUP/IRB# Research Integrity and Compliance Institutional Biosafety Committee APPROVAL BIOSAFETY REGISTRATION FORM Tel: (215)
More informationIS THE US FDA REGULATION AND EVALUATION OF GENETICALLY ENGINEEERED FOODS SUFFICIENT? Teresa Marek FOOD REGULATION IN THE UNITED STATES
IS THE US FDA REGULATION AND EVALUATION OF GENETICALLY ENGINEEERED FOODS SUFFICIENT? by Teresa Marek FOOD REGULATION IN THE UNITED STATES Professor Neal Fortin April 25, 2008-1 - IS THE US FDA REGULATION
More informationCompatibility of Breeding Techniques 1 in Organic Systems
1 2 IFOAM Organics International position paper Compatibility of Breeding Techniques 1 in Organic Systems 3 4 5 6 7 8 9 10 11 12 13 14 15 The rapid development of genetic engineering techniques is leading
More informationWisconsin Briefs. from the Legislative Reference Bureau GENETICALLY MODIFIED CROPS. Brief December 2012
Wisconsin Legislative Reference Bureau Wisconsin Briefs from the Legislative Reference Bureau Brief 12-10 December 2012 GENETICALLY MODIFIED CROPS INTRODUCTION The development of genetically modified (GM)
More informationGenetically Engineered Foods
Genetically Engineered Foods Review of New Mandatory Disclosures February 10, 2017 Current Federal GMO Regulatory Framework EPA USDA FDA U.S. Department of Agriculture (USDA), Environmental Protection
More informationRegulation of Biotechnology
Section V 1988-2009 Environment Books Inc. Page D1 Regulation of Biotechnology Summary of the Requirement: Any person who intends to manufacture or import for commercial purposes 1 a new 2 living microorganism
More informationShipping Biological Materials Quick Reference Guide
* This document provides UC Berkeley researchers a quick overview of government requirements and internal policy for transporting biological materials, either to or from campus. For additional information
More informationAdvanced Plant Technology Program Vocabulary
Advanced Plant Technology Program Vocabulary A Below you ll find a list of words (and their simplified definitions) that our researchers use on a daily basis. Abiotic stress (noun): Stress brought on by
More information1 THE GENE TECHNOLOGY ACT INVITATION TO PUBLIC DEBATE. The Gene Technology Act Invitation to Public Debate
1 THE GENE TECHNOLOGY ACT INVITATION TO PUBLIC DEBATE 2018 The Gene Technology Act Invitation to Public Debate CONTENT Chief Editor: Ole Johan Borge Case officer: Sigrid Bratlie Publisher: The Norwegian
More informationBiotechnology. Chapter 20. Biology Eighth Edition Neil Campbell and Jane Reece. PowerPoint Lecture Presentations for
Chapter 20 Biotechnology PowerPoint Lecture Presentations for Biology Eighth Edition Neil Campbell and Jane Reece Lectures by Chris Romero, updated by Erin Barley with contributions from Joan Sharp Copyright
More informationMAS refers to the use of DNA markers that are tightly-linked to target loci as a substitute for or to assist phenotypic screening.
Marker assisted selection in rice Introduction The development of DNA (or molecular) markers has irreversibly changed the disciplines of plant genetics and plant breeding. While there are several applications
More informationUpdate on the IVDR. Sue Spencer
Update on the IVDR Sue Spencer Caution The new regulations are draft the principles have now been agreed but the Annexes are subject to minor changes Further details will be added later pre and post application
More informationEuropean Union Reference Laboratory for Genetically Modified Food and Feed (EURL GMFF)
Guideline for the submission of DNA sequences derived from genetically modified organisms and associated annotations within the framework of Directive 2001/18/EC and Regulation (EC) No 1829/2003 European
More informationRegulations and safety assessment for genetically modified foods and feeds in Taiwan
Regulations and safety assessment for genetically modified foods and feeds in Taiwan Wen-Shen Chu Food Industry Research and Development Institute 21 July, 2016 1 Contents Overview of Taiwan Regulatory
More informationGMO Technology Conference
GMO Technology Conference The regulation of Clinical Trials on humans involving therapies containing or consisting of genetically modified organisms The Printworks, Dublin Castle 10 th & 11 th October
More informationPROCESS MANAGEMENT MANUAL FOR RELEASE INTO THE ENVIRONMENT OF GENETICALLY MODIFIED AGRICULTURAL ORGANISMS
PROCESS MANAGEMENT MANUAL FOR RELEASE INTO THE ENVIRONMENT OF GENETICALLY MODIFIED AGRICULTURAL ORGANISMS By Adelaida Harries Seed Science Center/Biosafety Institute for Genetically Modified Agricultural
More informationNew Plant Breeding Techniques. March 2015, Singapore
New Plant Breeding Techniques March 2015, Singapore IGTC Business Plan 2015-2018 Main topics : Grain as a hazardous product Development of a standard for the International Movement of Grain Global Low
More informationInformation as required by the Cartagena Protocol on Biosafety and the national biosafety legislation:
DIRECTORATE GENETIC RESOURCES Private Bag X973, Pretoria, 0001 Harvest House Room 167, 30 Hamilton Street, Arcadia, Pretoria, 0002 Tel: (+27) 12 319 6382, Fax: (+27) 12 319 6298, E-mail: NompumeleloM@daff.gov.za
More information3. At least one individual with expertise in animal containment practices.
Title: Approval Date: May 15, 2015 Effective Date: May 15, 2015 A. Purpose The (IBC) reviews recombinant or synthetic nucleic acid molecules research (r/s DNA) conducted at or sponsored by the University
More informationRecombinant DNA Technology. The Role of Recombinant DNA Technology in Biotechnology. yeast. Biotechnology. Recombinant DNA technology.
PowerPoint Lecture Presentations prepared by Mindy Miller-Kittrell, North Carolina State University C H A P T E R 8 Recombinant DNA Technology The Role of Recombinant DNA Technology in Biotechnology Biotechnology?
More informationGMO Crops, Trade Wars, and a New Site Specific Mutagensis System. A. Lawrence Christy, Ph.D.
GMO Crops, Trade Wars, and a New Site Specific Mutagensis System A. Lawrence Christy, Ph.D. Background PhD in Plant Physiology from Ohio State University 12 years with Monsanto R&D in PGR s and herbicides
More informationRegistration for the Use of Biological Materials
Form 01: Please return to: Registration for the Use of Biological Materials Environmental Health and Safety (EHS) 135 College St., Suite 100 Tel. 737-2121 Fax 785-7588 OEHS Use Only BSL: BBP State Select
More informationThe process of new DNA to another organism. The goal is to add one or more that are not already found in that organism.
Genetic Engineering Notes The process of new DNA to another organism. The goal is to add one or more that are not already found in that organism. Selective Breeding Carefully choosing which plants and
More informationWhat is Genetic Engineering?
Selective Breeding Selective Breeding is when someone (humans) breed organisms with specific traits in order to produce offspring having those same traits. This is also called artificial selection, the
More information18.0 INSTITUTIONAL BIOSAFETY COMMITTEE
18.0 INSTITUTIONAL BIOSAFETY COMMITTEE 18.1 INTRODUCTION... 1 18.2 BIOLOGICAL SAFETY COMMITTEE SCOPE AND MISSION STATEMENT... 1 18.3 DEFINITION OF A BIOLOGICAL AGENT... 2 18.4 REVIEW CLASSIFICATION...
More informationIntroducing new DNA into the genome requires cloning the donor sequence, delivery of the cloned DNA into the cell, and integration into the genome.
Key Terms Chapter 32: Genetic Engineering Cloning describes propagation of a DNA sequence by incorporating it into a hybrid construct that can be replicated in a host cell. A cloning vector is a plasmid
More informationAN UPDATE ON INDIAN BIOSAFETY REGULATORY SYSTEM. Dr. Vibha Ahuja Biotech Consortium India Limited
AN UPDATE ON INDIAN BIOSAFETY REGULATORY SYSTEM Dr. Vibha Ahuja Biotech Consortium India Limited STRUCTURE OF PRESENTATION 1. Existing regulatory framework in India 2. New Acts/policies dealing with GM
More informationInstitutional Biosafety Committee. Policies and Procedures
Institutional Biosafety Committee Policies and Procedures September 2011 CONTENTS 1. INTRODUCTION 1.1 UNLV Institutional Biosafety Committee Roles and Responsibilities 1.2 The Foundation for IBC Review:
More informationVegetative and Cutting Propagation
15 Vegetative and Cutting Propagation Text Pages: 597 601; 623 628. Objectives: 1. Be able to describe and explain the origins of clones. 2. Be able to describe, explain, and summarize managing sources
More informationPEST RISK ANALYSIS FOR QUARANTINE PESTS
ISPM 11 INTERNATIONAL STANDARDS FOR PHYTOSANITARY MEASURES ISPM 11 PEST RISK ANALYSIS FOR QUARANTINE PESTS (2013) Produced by the Secretariat of the International Plant Protection Convention FAO 2014 Publication
More informationUnapproved Genetically Modified Wheat Discovered in Oregon and Montana: Status and Implications
Discovered in Oregon and Montana: Status and Implications name redacted Analyst in Natural Resources and Rural Development December 4, 2014 Congressional Research Service 7-... www.crs.gov R43100 Summary
More informationBIOSAFETY REGISTRATION FORM
BRF 5/2015 Page 1 of 5 COMMITTEE USE ONLY 1. PERSONNEL TEMPLE UNIVERSITY Office of the Vice Provost for Research Division of Research Compliance Institutional Biosafety Committee Tel: (215) 707-9741, Fax:
More informationQ. Importing better varieties of plants from outside and acclimatizing i them to local l environment is 1. Selection 2. Cloning 3. Introduction 4. Het
CET BIOLOGY BIOTECHNOLOGY II Q. Importing better varieties of plants from outside and acclimatizing i them to local l environment is 1. Selection 2. Cloning 3. Introduction 4. Heterosis Q. Bagging is done
More informationChapter 9 Genetic Engineering
Chapter 9 Genetic Engineering Biotechnology: use of microbes to make a protein product Recombinant DNA Technology: Insertion or modification of genes to produce desired proteins Genetic engineering: manipulation
More informationSTUDY GUIDE ARE GMOS GOOD OR BAD? KEY TERMS: genes DNA genetically-modified
STUDY GUIDE ARE GMOS GOOD OR BAD? KEY TERMS: NOTE-TAKING COLUMN: Complete this section during the video. Include definitions and key terms. genes DNA genetically-modified seeds Monsanto How long have humans
More informationGenetics and Biotechnology Chapter 13
1 Genetics and Biotechnology Chapter 13 Selective breeding is used to produce organisms with desired traits. I. Applied Genetics A. Selective Breeding 1. Definedthe process by which desired traits of certain
More information